Dutch trial with Viagra halted after 11 babies die

The Hope Was Viagra Could Help Babies. Instead, 11 Died

Eleven babies die as pregnant women are given Viagra during drug trial

A Dutch drug trial in which pregnant mothers were given Viagra has been halted after 11 babies died shortly after birth.

The Dutch study, which started in 2015, looked at possible beneficial effects of increased blood flow to the placenta in mothers whose unborn babies were severely underdeveloped.

The Dutch trial was created to investigate whether Viagra was useful in promoting the growth of severely underdeveloped babies in the womb.

The research, conducted in 10 hospitals throughout the Netherlands, involved 183 pregnant women whose babies had a severe growth limitation early in pregnancy.

Although there is nothing to suggest the link between the trial and the deaths, the speculation is that the children died since Viagra caused high blood pressure in the lungs.

There are still 15 women in the trial who have yet to give birth
There are still 15 women in the trial who have yet to give birth

The hope was that the drug "can open up some blood vessels in the placenta and then can help the growth of the fetus", Pammi said.

Out of the placebo group, nine babies died, none of them from lung disease. Six other newborns were also diagnosed with a lung condition that breached their ability to obtain sufficient oxygen, however, these 6 did survive.

'All adverse effects occurred after birth. But that trial also failed to show a benefit.

He said: "The likelihood of developing a lung condition was much higher (among Viagra takers), as was the chances of death shortly after birth".

In total, 93 women were given the drug as part of the trial, led by Amsterdam University Medical Centre.

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A team led by Kenneth Lim at the University of British Columbia is part of an global research effort looking at the effectiveness of sildenafil, the generic name of Viagra, in treating women with a condition called early-onset intrauterine growth restriction.

In the control group, three babies had the same lung disease but none of them died, according to reports.

He told NOS that 10 to 15 women who took part do not yet know what the outcome will be for their baby: some are still pregnant, and a number of parents have babies in intensive care.

The statement from the medical center said sildenafil is sometimes used to treat women whose babies seem to not be growing well and noted that the practice will probably be discontinued.

Sildenafil is the active ingredient in popular erectile dysfunction medications like Viagra, but the study did not involve Viagra nor a generic form authorized by Viagra's creator, Pfizer.

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But she supports the decision made by Dutch investigators to discontinue to the study.

In a statement, Amsterdam UMC said that it believed the trial had been conducted properly, but will launch an external investigation to find the cause of deaths.

Doctors intend to "extensively" analyze all the data they've been able to collect so far, and "the development of the children will be closely monitored".

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